Clinical Trial

Proton Pump Inhibitor (PPI) Response in Eosinophilic Esophagitis Assessed by Transnasal Endoscopy (TNE)

Unknown Phase 4
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Record status
This record was last updated July 3, 2024 (before its estimated August 2024 completion). Its status may not reflect the trial's current state.
Summary
This study will enroll participants who have been diagnosed with Eosinophilic Esophagitis (EoE). Upon study enrollment, the participant will begin a proton pump inhibitor (PPI), Omeprazole 20mg twice daily. After taking Omeprazole for four weeks, the participant will have a Transnasal Endoscopy, and biopsies will be taken to determine the histological change. If the biopsies are abnormal, the participant continues Omeprazole and will undergo another endoscopy at eight weeks. The study aims to determine the percentage of children with Eosinophilic Esophagitis who improve with PPI use and to determine the length of time and effectiveness of PPI therapy in the management of EoE. The investigators hypothesize that following the initiation of PPI for treatment of Eosinophilic Esophagitis, biopsies obtained will show decreasing eosinophil counts at four weeks, which is sooner than the previously reported eight-week period.
Protocol Amendment History 1 change
critical Trial status changed: Active, Not Recruiting → Unknown 2026-08-02
Trial Details
NCT Number NCT04149470
Lead Sponsor University of Colorado, Denver
Collaborators: Children's Hospital Colorado
Conditions Eosinophilic Esophagitis
Enrollment 90 participants
Start Date 2020-10-07
Primary Completion 2024-08 (estimated)
Study Completion 2024-08 (estimated)
Updated on ClinicalTrials.gov 2024-07-03